Trouble shooting accelerator system for implantable drug delivery pumps

ABSTRACT

An implantable pump and methods for detecting leaks in an implantable pump are provided. In one embodiment, the implantable drug pump includes a housing having at least one inlet port and an outlet port formed therein. The outlet port is adapted to communicate with a catheter for delivering fluid to a patient&#39;s body, and the inlet port(s) are effective to deliver fluid into the housing. The housing further includes at least one reservoir disposed therein and effective to contain a fluid. In use, the pump preferably includes a fluid having one or more drugs disposed in at least one of the reservoirs, and a radiolucent fluid disposed in one of the reservoirs. A user programmable control mechanism is coupled to the drug pump and is effective to selectively control movement of the valves between the open and closed positions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/348,812 filed on Jan. 22, 2003 now U.S. Pat. No. 6,902,544 andentitled “Troubleshooting Accelerator System for Implantable DrugDelivery Pumps,” which is hereby incorporated by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to implantable drug pumps and methods fordetecting leaks in an implantable drug pump.

BACKGROUND OF THE INVENTION

Implantable drug delivery devices are commonly used to provide sitespecific and/or sustained delivery of beneficial agents to addressadverse patient conditions. The pumps are used for the continuousmedication delivery over relatively long periods of time in patients whocould otherwise only be treated by injecting the medications, such as,e.g., morphines, heparins and similar drugs, several times daily. Pumpsare advantageous in comparison with injections in that an even flow rateand a significantly lower total intake of the drug can be realized.

Implantable drug pumps typically include a reservoir for storing afluid, such as a drug, and a pump or other flow control device todeliver the fluid to a site within a patient. A septum is formed on thetop of the pump to allow refilling of the reservoir. Most implantablepumps also include a bolus port which is coupled to the catheter toenable a one-time injection directly to the treatment site. In use, thepump is disposed in a subcutaneous pocket in the area of the abdomen ofthe patient whereby the refill opening sealed by the septum is palpableunder the skin of the patient. The medication reservoir is filled bypiercing the skin of the patient and the septum with the correspondingneedle of a syringe.

While implantable pumps have been proven to be highly effective, onedisadvantage of current designs is the inability to detect leaks in thecatheter extending from the pump to the drug delivery site, or betweenthe catheter and the outlet port. Currently, leak detection requires thedrug to be removed from the drug reservoir, and sodium chloride to beintroduced through the refill port. The pump is then set to dispense thesodium chloride until any residual drug is removed from the reservoir.This process alone can take several days to complete. Once the reservoiris emptied, a contrast agent can then be introduced through the bolusport. An x-ray image of the contrast agent flowing through the catheteris then taken to detect any leaks.

Accordingly, there is a need for improved drug pumps, and for methodsfor detecting leaks in a drug pump.

SUMMARY OF THE INVENTION

In general, the present invention provides implantable drug pumps andmethods for detecting leaks in an implantable drug pump. In oneembodiment, an implantable drug pump is provided having a housingincluding an inlet port and an outlet port formed therein. The outletport is adapted to communicate with a catheter for delivering fluid to apatient's body, and the inlet port is effective to deliver fluid intothe housing. The housing further includes at least one reservoirdisposed therein that is effective to contain a fluid. In use, the pumppreferably includes a fluid having one or more drugs disposed in atleast one of the reservoirs, and a radiolucent fluid disposed in anotherone of the reservoirs. A user programmable control mechanism is coupledto the drug pump and is effective to selectively control movement of thevalves between the open and closed positions.

In one embodiment, the reservoirs can be selectively rotatable withinthe housing such that any one of the reservoirs can be positioned to bein fluid communication with the outlet port, and any one of thereservoirs can be positioned to be in fluid communication with the inletport. The pump further includes at least one valve disposed between thereservoirs and the outlet port. The valve is effective to control theflow of fluid from the reservoirs to the outlet port. A driver mechanismis provided and is effective to selectively drive fluid from thereservoirs to the outlet port.

In another embodiment the drug pump can include several valves, eachvalve being in communication with one of the reservoirs and in fluidcommunication with the outlet port. A controller is preferably incommunication with each of the valves for selectively moving each of thevalves between an open position and a closed position. An externalprogrammer is preferably provided for actuating the controller. In anexemplary embodiment, each valve includes a latch member mated to aplunger movable between an open and closed position, and an actuatormechanism effective to actuate the latch member and move the plungerbetween the open and closed positions. The actuator mechanism ispreferably a piezoelectric actuator, however a variety of actuatormechanisms can be used.

In yet another embodiment of the present invention, an implantable drugpump is provided having a housing including an inlet port and aplurality of outlet ports formed therein. The plurality of outlet portsare adapted to communicate with at least one catheter for deliveringfluid to a patient's body, and the inlet port is effective to deliverfluid into the housing. The pump further includes a plurality ofreservoirs disposed within the housing and effective to contain a fluidtherein. Each of the plurality of reservoirs is in fluid communicationwith at least one of the plurality of outlet ports and with the inletport. The pump also includes a plurality of valves, each valve beingdisposed between one of the plurality of reservoirs and one of theplurality of outlet ports. The plurality of valves are effective tocontrol the flow of fluid from the plurality of reservoirs to theplurality of outlet ports. The pump can also include a driver mechanismeffective to selectively drive fluid from the plurality of reservoirs tothe plurality of outlet ports.

A method for detecting a leak in an implantable drug pump is alsoprovided. The method includes the step of providing an implantable drugpump having a housing including a first reservoir disposed therein andcontaining a fluid having one or more drugs, and a second reservoirdisposed therein and containing a radiolucent fluid. The housing furtherincludes at least one inlet port formed therein that is in communicationwith at least one of the first and second reservoirs, an outlet portformed therein and adapted to deliver a fluid to a patient's body. Afirst programmable valve is in fluid communication with the firstreservoir and the outlet port. The first valve is movable between aclosed position, in which fluid is prevented from flowing from the firstreservoir to the outlet port, and an open position, in which fluid isfree to flow from the first reservoir to the outlet port. A secondprogrammable valve is in fluid communication with the second reservoirand the outlet port. The second valve is movable between a closedposition, in which fluid is prevented from flowing from the secondreservoir to the outlet port, and an open position, in which fluid isfree to flow from the second reservoir to the outlet port. The pump alsoincludes a driver mechanism effective to drive fluid from the first andsecond reservoirs to the outlet port for delivering fluid to a patient'sbody. The method further includes the steps of causing the first valveto move to the closed position, causing the second valve to move to theopen position, and actuating the driver mechanism to cause theradiolucent fluid disposed within the second reservoir to flow throughthe valve and into the outlet port to be delivered to a patient's body.The flow of radiolucent fluid through the pump can be radiographicallyviewed to determine if any leaks exist in the implantable drug pump.Prior to the steps of programming the first and second valves andactuating the driver mechanism, the radiolucent fluid can optionally beintroduced into the second reservoir through the second inlet port.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is schematic diagram illustrating one embodiment of animplantable pump having two reservoirs according to the presentinvention;

FIG. 2 is a schematic diagram illustrating another embodiment of animplantable pump having multiple reservoirs according to the presentinvention;

FIG. 3A is a side, sectional view illustration of an implantable pumpconfigured in accordance with the diagram shown in FIG. 2;

FIG. 3B is a top view of the pump shown in FIG. 3A;

FIG. 4A is a top view illustration of an implantable pump according toanother embodiment of the present invention;

FIG. 4B is a side view illustration of the implantable pump shown inFIG. 4A;

FIG. 5A is a side view illustration of a valve in an open position inaccordance with one embodiment of the present invention;

FIG. 5B is a side view illustration of the valve shown in FIG. 5A in atransitional state moving from the open position to a closed position;and

FIG. 5C is a side view illustration of the valve shown in FIG. 5B is aclosed position.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides implantable drug pumps and methods fordetecting leaks in an implantable drug pump. In general, the implantabledrug pump includes a housing having an inlet port and at least oneoutlet port formed therein. The outlet port is adapted to communicatewith a catheter for delivering fluid to a patient's body, and the inletport is effective to deliver fluid into two or more reservoirs disposedwithin the housing and effective to contain the fluid. The reservoirscan be fixedly disposed within the housing, or alternatively thereservoirs can be selectively rotatable within the housing such that anyone of the reservoirs can be positioned to be in fluid communicationwith at least one outlet port, and any one of the reservoirs can bepositioned to be in fluid communication with the inlet port. The pumpcan also include at least one valve disposed between the reservoirs andthe outlet port. The valve is effective to control the flow of fluidfrom at least one of the reservoirs to the outlet port. A drivermechanism is also provided and is effective to selectively drive fluidfrom the reservoirs to the outlet port. Preferably, the driver mechanismselectively applies a force to at least one of the reservoirs to causefluid disposed therein to be forced through the valve, when open, andout the outlet port.

FIG. 1 illustrates a schematic diagram of one embodiment of animplantable drug pump 10 according to the present invention. The pump10, and the pump components, can each have a variety of shapes, sizes,and configurations. The pump 10 should, however, be adapted to beimplanted within a patient's body. As shown in FIG. 1, the pump 10includes a housing 12 having first and second reservoirs 14, 16 disposedtherein and adapted to contain an amount of fluid. The reservoirs 14, 16are each preferably formed from a bellows that is compressible uponapplication of a force thereto. Each reservoir 14, 16 is coupled to anoutlet port 30 formed in the housing 12 and to first and second inletports 18, 20, respectively. Fluid can be introduced into the firstreservoir 14 through the first inlet port 18 and the second reservoir 16through the second inlet port 20, and fluid can exit each reservoir 14,16 through the outlet port 30. The pump 10 can also optionally include abolus port 32 coupled directly to the outlet port 30 for enabling thedirect delivery of fluid to a patient via catheter 34.

The pump 10 further includes first and second valves 22, 24 disposedbetween the outlet port 30 and the first and second reservoirs 14, 16,respectively. The valves 22, 24 are effective to control the flow offluid from the reservoirs 14, 16 to the outlet port 30, and each valve22, 24 is coupled to a controller 28 disposed within the housing 12. Thecontroller 28 is effective to selectively move each valve 22, 24 betweenan open position and a closed position. An external programmer 36 can beprovided for transmitting a signal to the controller 28 to actuate thevalves 22, 24. An exemplary embodiment of a valve for use with a pumpaccording to the present invention will be described in more detail withrespect to FIG. 5.

The housing 12 further includes a driver mechanism 26 adapted to drivefluid from the first and second reservoirs 14, 16 through the first andsecond valves 22, 24, when in the open positions, and out the outletport 30 whereby the fluid can be delivered to a treatment site within apatient via a catheter 34. A variety of driver mechanisms 26 can be usedwith the present invention, including both constant-pressure drivermechanisms and programmable driver mechanisms that can apply pressure atvariable, programmed rates. The driver mechanism 26 can also be adaptedto selectively apply pressure to only one reservoir at a time, oralternatively, the pump 10 can include a separate driver mechanismcoupled to each reservoir. The driver mechanism 26 can also optionallybe adapted to apply a pulsatile pressure to each reservoir. Suitabledriver mechanisms 26 include, for example, a compression spring, apropellant gas, and an electromechanical actuator.

In use, the pump 10 is implanted within a patient, and the first andsecond reservoirs are filled with fluid, via the inlet ports 18, 20,either prior to or after implantation of the pump 10. The pumpprogrammer 36 is then used to send a signal to the controller to movethe valves 22, 24 between the open and closed positions, and optionallyto activate the driver mechanism 26, depending on the type of drivermechanism 26 used. As the driver mechanism 26 applies a force to one orboth of the reservoirs 14, 16, if the valves 22, 24 are open, fluid isforced out of one or both of the reservoirs 14, 16 and travels throughthe outlet port 30 to be delivered to a drug delivering site within thepatient via catheter 34.

FIG. 2 illustrates another embodiment of an implantable drug pump 40.The pump 40 is similar to the pump 10 shown in FIG. 1, except that thepump 40 includes multiple reservoirs 44, 46, 48. Each reservoir 44, 46,48 includes an inlet port 50, 52, 54 for introducing fluid into thereservoir 44, 46, 48, and a valve 58, 60, 62 for controlling the flow offluid from the reservoir 44, 46, 48 to an outlet port 64. While only oneoutlet port 64 is illustrated, each reservoir 44, 46, 48 can optionallybe individually coupled to an outlet port that is in communication witha catheter. This allows fluid to be delivered to difference treatmentsites within a patient's body.

The pump 40 operates similar to pump 10 shown in FIG. 1, wherein adriver mechanism 56 is provided for applying a pressure to one or moreof the reservoirs 44, 46, 48 to force fluid out of the reservoir 44, 46,48 when the valve 58, 60, 62 is in the open position. The pump 40 isparticularly advantageous in that various combinations of drugs can beadministered to a patient individually or simultaneously. Moreover, oneof the reservoirs 44, 46, 48 can be reserved for retaining a radiolucentfluid used for testing the pump 14 for leaks.

FIGS. 3A and 3B illustrate an exemplary embodiment of a pump 80constructed in accordance with the schematic diagram shown in FIG. 2. Asshown, the pump 80 includes a housing 82 having first, second, and thirdreservoirs 84, 86, 88 disposed therein. The housing 82 can have avariety of shapes and sizes, but is preferably cylindrical and has asize adapted to contain the pump components. Each reservoir 84, 86, 88can also vary in shape and size, but preferably each reservoir 84, 86,88 has a cylindrical shape and is formed from a bellows. The pump 80further includes first, second, and third inlet ports 92, 94, 96 influid communication with the first, second, and third reservoirs 84, 86,88, respectively, and an outlet port 102 fluidly coupled to all threereservoirs 84, 86, 88. A valve 98, 100 (third valve is not shown) isdisposed between each reservoir 84, 86, 88 and the outlet port 102 tocontrol fluid flow from the reservoirs 84, 86, 88 to the outlet port102.

The pump 80 can also include a variety of additional features including,for example, a controller 104 disposed within the housing 82. Thecontroller 104 is preferably disposed in the chambers 104 between thereservoirs 84, 86, 88 for effecting movement of each valve 98, 100between an open position and a closed position. As previously describedwith respect to FIGS. 1 and 2, an external programmer can be used totransmit a signal to the controller 104 to effect movement of each valve98, 100 between the open and closed positions. The pump 80 alsopreferably includes a driver mechanism 90 that is effective to applypressure to one or more of the reservoirs 84, 86, 88 to drive fluid outof the reservoirs 84, 86, 88. As previously described above, a varietyof driver mechanisms can be used with a pump according to the presentinvention, including, for example, a propellant gas.

A person having ordinary skill in the art will appreciate that theconfiguration of the driver mechanism 90 can vary, and that one or moredriver mechanisms 90 can be provided to enable each reservoir 84, 86, 88to be actuated either simultaneously or independently of one another. Byway of non-limiting example, a single driver mechanism can be providedto apply pressure to all three reservoirs simultaneously, oralternatively, each reservoir can be coupled to a separate drivermechanism thereby allowing each reservoir to be actuated independently.In yet another embodiment, the driver mechanism 90 can be movablydisposed within the housing to allow the driver mechanism to bepositioned adjacent any one or more of the reservoirs to drive fluidtherefrom.

A person having ordinary skill in the art will appreciate that the pumpcan include a variety of other features not shown or described herein.By way of non-limiting example, the pump can include a bolus port influid communication with the outlet port. In use, fluid can be injectedinto the bolus port, whereby it flows directly out of the outlet portand is delivered to the patient. The pump also preferably includes aflow-restrictor mechanism disposed between each reservoir and the valve.The flow-restrictor mechanism is effective to control the rate of fluidflow from the reservoir to the valve.

FIGS. 4A and 4B illustrate another embodiment of an implantable pump 110that includes a housing 112 having several reservoirs 114 a–hrotationally disposed therein. The housing 112 can have any shape andsize, but is preferably cylindrical and includes a proximal end 115, adistal end 117, and a sidewall 119 extending therebetween and forming aninner chamber adapted to contain the reservoirs 114 a–h and other pumpcomponents. The pump 110 further includes an inlet port 116 adapted tocommunicate with one of the reservoirs 114 a–h, and an outlet port 118preferably adapted to communicate with another one of the reservoirs 114a–h. The inlet and outlet ports 116, 118 can be positioned anywhere inthe housing 112, but preferably the inlet port 116 is formed in theproximal end 115 of the housing 112, and the outlet port 118 is formedin the sidewall 119 of the housing 112 and positioned apart from theinlet port 116.

Each of the reservoirs 114 a–h can have virtually any shape or size, butthe reservoirs 114 a–h should be adapted to rotate simultaneously aroundan axis to enable at least one of the reservoirs 114 a–h to be fluidlycoupled to the inlet port 116, and at least one of the reservoirs 114a–h to be fluidly coupled to the outlet port 118. Preferably, thereservoirs 114 a–h rotate simultaneously around a central axis A—A (FIG.4B) extending through the pump 110 from the proximal end 115 to thedistal end 117. As shown in FIG. 4A, rotation of the reservoirs 114 a–henables one of the reservoirs 114 a–h, e.g., reservoir 114 d, to becoupled to the inlet port 116, and one of the reservoirs 114 a–h, e.g.,114 h, to be coupled to the outlet port 118. A variety of techniques canbe used to effect movement of the reservoirs within the housing,including both mechanical and electrical actuators. Preferably, movementof the reservoirs is controlled by the programmer via a controller (notshown) disposed within the pump.

The pump can also include a variety of other features similar to thosepreviously described with respect to FIGS. 1–3B. By way of non-limitingexample, the pump 220 preferably includes a valve (not shown) coupled tothe outlet port 118 for controlling the flow of fluid from thereservoir, e.g., reservoir 114 h, to the outlet port 118 and thecatheter (not shown). An exemplary embodiment of a valve will bedescribed in more detail with reference to FIGS. 5A–5C. The pump 110further includes a driver mechanism (not shown) that is preferablypositioned adjacent the outlet port 118, and that is effective to applya force to the reservoir, e.g. reservoir 114 h, coupled to the outletport 118. A variety of driver mechanisms can be used, including thosedriver mechanisms described above with respect to FIGS. 1–3B.

The present invention also provides a method of using a pump. While themethod can be employed using virtually any pump, including thosedescribed herein, the method is described in connection with FIG. 1 forillustration purposes only. Referring to FIG. 1, the pump 10 preferablycontains a marking agent to enable the pump and/or the catheter 34 to betested for leaks. Preferably, one of the reservoirs, e.g., the firstreservoir 14, contains a drug disposed therein, and the other reservoir,e.g., the second reservoir 16, includes a radiolucent fluid disposedtherein. The radiolucent fluid can be a marking agent, or a mixture of amarking agent and a physiologically acceptable sodium chloride solution.The marking agent and/or sodium chloride solution can be predisposedwithin the reservoir 16 prior to implantation of the pump 10, or it canbe injected into the reservoir 16 via inlet port 20. Preferably, sodiumchloride solution is disposed within the reservoir 16, and the markingagent is injected into the reservoir 16 prior to testing the pump 10 forleaks. Once the marking agent is disposed within the second reservoir16, the programmer 36 can be used to transmit a signal to the controller28 to move the first valve 22 to the closed position, thereby preventingany fluid from exiting the first reservoir 14, and to move the secondvalve 24 to the open position, thereby allowing fluid to flow from thesecond reservoir 16 through the outlet port 30 and to the treatment sitevia catheter 34. The programmer 36 can also optionally be used to send asignal to the driver mechanism 26 where a variable driver mechanism 26is employed. While the fluid is flowing through the pump 10 and thecatheter 34, a radiographic image, e.g., an x-ray image, of the pump 10and catheter 34 can be taken and viewed to determine if any leaks existin the implantable drug pump 10 and/or catheter 34. This is particularlyadvantageous in that the first reservoir 14 containing the drug does notneed to be drained and cleaned to allow the pump 10 to be tested forleaks.

A person having ordinary skill in the art will appreciate that the pumpsdescribed herein are not limited to use with a marking agent, and that avariety of drugs can be disposed within the pump and used to treat apatient.

FIGS. 5A–5C illustrate an exemplary embodiment of a valve 120 for usewith an implantable pump. As shown, the valve 120 includes a housing 122having an inlet 124, an outlet 125, and an inner lumen 126 extendingtherebetween. A movable flow control member, e.g., a plunger, isdisposed adjacent the inner lumen 126 and includes a proximal portion129 and a distal portion 128 having an inner lumen 127 (shown in FIG.5B) extending therethrough. The flow control member 128, 129 is movablebetween an open position, as shown in FIG. 5A, in which inner lumen 127is aligned with the inner lumen 126 of the housing 122, and a closedposition, shown in FIGS. 5B and 5C, in which the distal portion 128 ofthe flow control member is moved proximally so that inner lumen 127 isoffset from inner lumen 126, thereby blocking inner lumen 126 to preventfluid from flowing through the housing 122.

The flow control member 128, 129 is coupled to a piezoelectric systemwhich includes several springs 146, 136, 140, a latch 132, and apiezoelectric actuator 130. The piezoelectric system is effective tomove the flow control member 128, 129 between the open and closedpositions. While a variety of actuation devices can be used, thepiezoelectric system includes a latch 132 having a portion positionedaround a receiving pin 134 that is coupled to a base structure 138, andan opposed portion that is coupled to the piezo actuator 130. A solenoid140 is mated to and/or disposed around the latch 132, and a springmember 136 is disposed around the receiving pin 134, and is adapted tobe compressed by the latch 132. The spring member 136 is preferably madefrom a ferromagnetic material such that DC voltage applied to thesolenoid 140 will generate a force that is effective to cause the latch132 to move toward the base structure 138, thereby compressing thespring 136. The piezoelectric actuator 130, which is positioned on theopposed side of the latch 132 from the spring 136, can have a variety ofshapes, but preferably has a generally elongate shape and, uponapplication of a voltage applied thereto, moves between a first andsecond position, which will be described in more detail herein. Thepiezoelectric system can also include a receiving member 146 positionedon a side of the inner lumen 126 opposed to the flow control member 128,129. The receiving member 146 can be, for example, a spring mechanismeffective to receive a pressure applied thereto by the flow controlmember 128, 129. The valve 120 can also include other features such asan o-ring 148 disposed around a portion of the flow control member 128,129 for enabling movement of the flow control member 128, 129 betweenthe open and closed positions.

In use, the flow control member 128, 129 can be moved between the openand closed positioned by applying DC Voltage to the piezoelectricactuator and the solenoid, respectively. Referring to FIG. 5A, in whichno voltage is being applied, the flow control member 128, 129 is shownin the open position, whereby fluid is allowed to pass through the innerlumen 126 in the housing 122 and through the inner lumen 127 in the flowcontrol member 128, 129. Spring 136 is in the uncompressed positioned,while spring 146 is compressed by a downward force from the flow controlmember 128, 129. The piezoelectric actuator 130 is being engaged by thelatch 132 to hold the flow control member 128, 129 in a distal position,thereby applied a downward pressure to compress spring 146, and to allowfluid to flow through lumens 126 and 127.

FIG. 5B illustrates a transitional state as the flow control membermoves from the open position to the closed position. Movement of theflow control member can be activated by applying a DC Voltage to thesolenoid 140, which generates a force to move the latch 132 toward thebase structure 138, thereby compressing spring 136 and releasing thepiezoelectric actuator 130 from the engaged position. The flow controlmember 128, 129 can then move in a proximal direction to the closedposition, thereby blocking the flow of fluid through the lumen 126formed in the housing 122. Once the voltage source is shut off, thelatch 132 is then released and spring 136 is free to return to theuncompressed state, as shown in FIG. 5C. Movement of the latch 132 backto the original state engages and pushes the piezoelectric actuator 130upward in a proximal direction.

In order to return the flow control member 128, 129 to the openposition, DC Voltage can be applied to the piezoelectric actuator 130,thereby causing the actuator 130 to apply a distal force on the latch132 to push the latch 132 toward the base structure 138, therebycompressing spring 136. Once the actuator 130 moves distally past thelatch 130, the latch 132 is then released and spring 136 is free toreturn to the uncompressed state. The latch 32 then engages thepiezoelectric actuator 130 to hold the flow control member 128, 129 in adistal, open position, as shown in FIG. 5A.

A person having ordinary skill in the art will appreciate that a varietyof valves can be used with a pump according to the present invention,and that the valve can include a variety of actuation mechanisms. By wayof non-limiting example, both mechanical and electrical devices can beused to actuate the valve, include, for example, a shape memorymaterial.

One of ordinary skill in the art will appreciate further features andadvantages of the invention based on the above-described embodiments.Accordingly, the invention is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims. All publications and references cited herein are expresslyincorporated herein by reference in their entirety.

1. A method for detecting a leak in an implantable drug pump,comprising: causing a first valve of an implantable drug pump to movefrom an open position, in which fluid can flow from a first reservoirformed in a housing of the implantable drug pump to an outlet portformed in the housing of the implantable drug pump, to a closedposition, in which fluid is prevented from flowing from the firstreservoir to the outlet port; causing a second valve to move from aclosed position, in which fluid is prevented from flowing from a secondreservoir formed in the housing of the implantable drug pump to theoutlet port, to an open position, in which fluid is free to flow fromthe second reservoir to the outlet port; actuating a driver mechanism tocause a radiolucent fluid disposed within the second reservoir to flowthrough the second valve and into the outlet port to be delivered to apatient's body; and radiographically viewing the radiolucent fluidflowing through the implantable drug pump to determine if any leaksexist in the implantable drug pump and structures connected to theimplantable drug pump; wherein the implantable drug pump includes afirst inlet port in communication with the first reservoir, and a secondinlet port in communication with the second reservoir; wherein, prior tothe step of causing a second valve to move from a closed position to anopen position, the radiolucent fluid is introduced into the secondreservoir through the second inlet port.
 2. The method of claim 1,further comprising a catheter connected to the outlet port and adaptedto deliver a fluid to a patient's body, and wherein the flow ofradiolucent fluid through the pump and the catheter is radiographicallyviewed to determine if any leaks exist in the implantable drug pump andthe catheter.
 3. The method of claim 1, wherein the radiolucent fluidcomprises a marking agent.
 4. The method of claim 1, wherein the drivermechanism of the implantable drug pump is selected from the groupconsisting of a compression spring, a propellant gas, and anelectromechanical actuator.
 5. The implantable drug pump of claim 1,wherein the driver mechanism of the implantable drug pump is adapted toapply a force to at least one of the first and second reservoirs tocause fluid disposed within the reservoir to be forced through one ofthe first and second valves and the outlet port.
 6. The method of claim1, wherein the inlet port of the implantable drug pump comprises a bolusport adapted to allow a drug to be delivered directly to the outletport.
 7. The method of claim 1, wherein the radiolucent fluid comprisesa mixture of a marking agent and sodium chloride.
 8. The method of claim1, wherein the implantable drug pump further comprises a userprogrammable control mechanism coupled to the drug pump and effective toselectively control movement of each of the first and second valvesbetween the open and closed positions.